Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

• ClinicalTrials.gov Identifier: NCT03790033
• Recruitment Status: Completed
• First Posted: December 31, 2018
• Last Update Posted: September 1, 2021
• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Kyunghee University Medical Center; Kyung Hee University Hospital at Gangdong; Semyung University Affiliated Oriental Medical Hospital; Sangji University Oriental Medical Hospital
• Information provided by (Responsible Party): Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital

Study Description

Brief Summary:

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet

Condition or disease	Intervention/treatment	Phase
Cold Hypersensitivity	Drug: Ucha-Shinki-Hwan; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
• Actual Study Start Date: December 11, 2018
• Actual Primary Completion Date: August 14, 2019
• Actual Study Completion Date: September 14, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: UCHA group; 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company	Drug: Ucha-Shinki-Hwan; Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g; Other Name: Bosinji
Placebo Comparator: Placebo group; 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan	Drug: Placebo; placebo granule

Outcome Measures

Primary Outcome Measures :

1. Changes from baseline in visual analogue scale(VAS) [ Time Frame: At baseline, week 4, 8, 12 ]
   The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.

Secondary Outcome Measures :

1. Changes from baseline in body temperature [ Time Frame: At baseline, week 4, 8, 12 ]
   Changes from baseline in body temperature
2. Changes from baseline in WHO Quality of Life-BREF [ Time Frame: At baseline, week 4, 8, 12 ]
   It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
3. Changes from baseline in blood pressure [ Time Frame: up to 12 weeks ]
   assess for monitoring patient safety
4. Changes from baseline in Pulse rate [ Time Frame: up to 12 weeks ]
   assess for monitoring patient safety
5. Levels of AST [ Time Frame: At screening visit, week 8 ]
   liver function test for monitoring patient safety(IU/L)
6. Levels of ALT [ Time Frame: Kidney function test for monitoring patient safety(mmol/L) ]
   liver function test for monitoring patient safety(IU/L)
7. Levels of r-GTP [ Time Frame: Kidney function test for monitoring patient safety(mmol/L) ]
   liver function test for monitoring patient safety(IU/L)
8. Levels of BUN [ Time Frame: Kidney function test for monitoring patient safety(mmol/L) ]
   Kidney function test for monitoring patient safety(mmol/L)
9. Levels of Cr [ Time Frame: Kidney function test for monitoring patient safety(mmol/L) ]
   Kidney function test for monitoring patient safety(mmol/L)
10. Adverse event [ Time Frame: At week 4, 8, 12 ]

Other Outcome Measures:

1. Pattern Identification Questionnaire [ Time Frame: At screening visit ]
   This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 59 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Female subjects aged 19 to 59 years have a complaint of CHHF.
• Patients must include at least one or more of the following symptoms:
• Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
• Those who have the symptoms of extremely cold hands in cold temperature exposure;
• Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
• Those who have 4 cm or greater of VAS CHH score;
• A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
• Those who can comply with all study-related procedures, medications, and evaluations;
• Given a written informed consent form.

Exclusion Criteria:

• Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
• Those who have one or more finger gangrene or ulceration;
• Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
• Those who are diagnosed by autoimmune disease or have a positive ANA test result;
• Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
• Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
• Those who are diagnosed with diabetes;
• Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
• Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
• Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
• Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
• Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
• Those who are addicted to alcohol or drugs;
• Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
• Those who are diagnosed with malignant tumor
• Those who are currently participated in other clinical trials;
• Those who are able to understand and speak Korean;
• Those who are judged to be inappropriate for the clinical study by the researchers.

Contacts and Locations

Locations

Korea, Republic of

Kyung Hee University medical center at Gangdong

Seoul, Korea, Republic of, 02447

Sponsors and Collaborators

Gachon University Gil Oriental Medical Hospital

Kyunghee University Medical Center

Kyung Hee University Hospital at Gangdong

Semyung University Affiliated Oriental Medical Hospital

Sangji University Oriental Medical Hospital

Investigators

• Principal Investigator: Chan Yong Jun; Gachon University Gil Oriental Medicine Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ko Y, Sun SH, Go HY, Lee JM, Jang JB, Sung HK, Jang BH, Jeon CY, Ko SG. Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19110. doi: 10.1097/MD.0000000000019110.

• Responsible Party: Chan-Yong Jeon, Principal Investigator, Gachon University Gil Oriental Medical Hospital
• ClinicalTrials.gov Identifier: NCT03790033
• Other Study ID Numbers: ISEE_2018_UCHA
• First Posted: December 31, 2018
• Last Update Posted: September 1, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: not decided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chan-Yong Jeon, Gachon University Gil Oriental Medical Hospital:

Cold Hypersensitivity; Korean medicine; Ucha-Shinki-Hwan

Additional relevant MeSH terms:

Cryopyrin-Associated Periodic Syndromes; Hypersensitivity; Immune System Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases